Intravaginal Electrical Nerve Stimulation in Women With Non-contracting Pelvic Floor

NCT03319095 | Completed

• 1 other identifier: 73055317.8.0000.5440
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that about 30% of women cannot voluntarily contract the pelvic floor muscles (PFM). PFM training (PFMT) represents the first therapeutic option for the treatment of female urinary incontinence (UI), however the inability to contract this muscle makes PFMT unfeasible. The primary objective of this project is to evaluate clinically the efficacy of intravaginal electrical stimulation associated with verbal instructions to provide the ability of women to contract voluntary their PFM. The secondary objective is to evaluate the UI prevalence and impact on quality of life.

Conditions

Pelvic Floor; Muscle; Contraction; Electric Stimulation Therapy

Keywords

pelvic floor, muscle, electrical stimulation, physiotherapy

Outcome Measures

Primary Outcomes (1)

• Bidigital Vaginal Palpation

  The primary outcome will be assessed by bidigital vaginal palpation using the modified Oxford scale at baseline and after 10 weeks. The correct contraction of the PFM will be considered as the action of occlusion and elevation of the PFM around the examiner's fingers in the ventral and cranial directions. Therefore, it will be considered a clinically relevant improvement to obtain a score above 3 on the modified Oxford scale. The examination will be performed following the following steps: * The participant will receive information about the procedure, and basic anatomy of the PFM. * She will be placed in dorsal decubitus, with hips and knees flexed, feet supported and legs apart; * The examiner using a procedure glove will carefully insert the index and middle fingers into the vaginal canal; * The participant will be instructed to contract the PFM in order to raise and compress the examiner's fingers. * To conclude, the participant will be directed to completely relax the PFM.

  30 minutes

Secondary Outcomes (1)

• International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

  20 minutes

Study Arms (2)

Control

NO INTERVENTION

Control group: participants will receive only verbal instructions on PFM anatomy and function during the first assessment when women will be required to contract their pelvic floor muscle. The participants will have no contact with the service until the second assessment

Intervention

ACTIVE COMPARATOR

Intravaginal Electrical Nerve Stimulation: participants will be submitted to Intravaginal Electrical Nerve Stimulation

Device: Intravaginal Electrical Nerve Stimulation

Interventions

Intravaginal Electrical Nerve Stimulation DEVICE

The Intervention group will receive Intravaginal Electrical Nerve Stimulation using Quark® Dualpex equipment, once per week during 8 weeks. The selected current will be biphasic, and the stimulation parameters will be: 50 Hz frequency, pulse width of 200 microseconds, contraction time (Ton) of 5 seconds, relaxation time (Toff) of 10 seconds, intensity of current defined according to the sensitivity (tolerance) of the patient, and total stimulation time of 20 minutes once a week delivered by an experienced Physiotherapist. In the last 10 minutes of each electrical nerve stimulation session women will be requested to perform voluntary PFM contractions along with the contractions induced by the electrical stimulation. Women will not be instructed to perform any aditional exercise or therapy at home.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are routinely referred to the Lucy Montoro Rehabilitation Center of the Hospital das Clínicas of the University of São Paulo at Ribeirão Preto Medical School - HCFMRP-USP for the physiotherapeutic treatment of pelvic floor dysfunctions;
• Pelvic floor muscle function grade 0 (zero) or 1 evaluated by bidigital palpation (Modified Oxford Scale);
• Consent to participate in the study and signing of the free and informed consent form.

You may not qualify if:

• Women with associated neurological pathologies;
• Symptoms of vaginal or urinary tract infection;
• Prolapses classified above grade 2;
• Suspected or confirmed pregnancy and cognitive deficit that compromises the procedure.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, 14620000, Brazil

Location

Related Publications (1)

• Ignacio Antonio F, Bo K, Pena CC, Bueno SM, Mateus-Vasconcelos ECL, Fernandes ACNL, Ferreira CHJ. Intravaginal electrical stimulation increases voluntarily pelvic floor muscle contractions in women who are unable to voluntarily contract their pelvic floor muscles: a randomised trial. J Physiother. 2022 Jan;68(1):37-42. doi: 10.1016/j.jphys.2021.12.004. Epub 2021 Dec 21.

  PMID: 34952812 DERIVED

Study Officials

• Cristine HJ Ferreira, PhD

  Ribeirão Preto Medical School, University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The main investigators and assessor will be blinded in relation to the allocation of participants in the groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: December 12, 2017
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

BR (1)